• Gene Therapy: Commercial Challenges And Strategic Choices
    Gene Therapy: Commercial Challenges And Strategic Choices

    Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

  • 4 Key Ingredients Of A Robust Risk Management Framework
    4 Key Ingredients Of A Robust Risk Management Framework

    It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.

  • Patent Strategy And The Internet Of Medical Things
    Patent Strategy And The Internet Of Medical Things

    Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.

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Guidelines To Bring Your Biologic To Market: Are You Prepared? Guidelines To Bring Your Biologic To Market: Are You Prepared?

Are you up to the task of bringing a biologic to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.

ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

Special Handling Required: Considering The Clinical Supply Chain In Vaccine Trials

Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

Avoiding Hemolysis Blood Sample Collection Processing

Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

Buffer Management Solutions For Large-Scale Bioprocessing

How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

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5 ADC Manufacturing Challenges You Need To Know

Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.

ePRO Basics: 6 Key Success Factors

While providing site training at an Investigator Meeting recently, I came across some interesting comments from sites that were not familiar with using eDiaries or tablets to capture PRO or ClinRO data. By Jane Carter, Program Manager, CRF Health

MRC-5 Cultivation In Nunc High Density Cell Factory Systems Protocol

This protocol was developed to validate the performance of the Thermo Scientific Nunc High Density Cell Factory System (HDCF) for the culturing of MRC-5 cells.

It’s A Regional Sale For Contract Research/Manufacturing

During the last few weeks I had the opportunity to speak with three experienced and successful business development professionals in the pharmaceutical contract manufacturing arena. They asked to remain anonymous, so I will simply refer to them as Hu, Himani, and Henry. What I got from these discussions with three individuals from three different countries was contrasting views on outsourcing and the future direction of the contract research and manufacturing industry. You can look at these as different world views, or to put it more accurately, different regional views. 

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Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles



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Applying Six-Sigma Tools and Concepts in Clinical Research – A Process Improvement Guide June 6 - 6, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
8th World Congress on Mass Spectrometry June 10 - 11, 2019
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